# K193341: iCTmotor (WL-1)

- Pathway: 510(k) (Traditional)
- Applicant: Dentium Co., Ltd.
- Decided: Sep 4, 2020 after 276 days
- Product code: EBW (Controller, Foot, Handpiece And Cord)
- Device class: 1
- Regulation: 21 CFR 872.4200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K002469 (2001). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140308: Mastersurg / Expertsurg, Kaltenbach & Voigt GmbH (2014) Summary page 4.

## Indications for use
iCTmotor (WL-1) is intended for use in dental surgery and implantology. The main control unit is designed to operate a specific dental micro motor that drives dental handpieces to cut hard and soft tissues in the mouth and screw dental implants. iCTmotor (WL-1) is compatible with a handpiece equipped with connection according to ISO 3964.

Source page: https://510kreport.com/device/K193341
Methodology: https://510kreport.com/methodology